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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-1707

2. Registrant Information.

Registrant Reference Number: Prosar case 1-15933424

Registrant Name (Full Legal Name no abbreviations): The Hartz Mountain Corporation

Address: 400 Plaza Drive

City: Secaucus

Prov / State: New Jersey

Country: USA

Postal Code: 07094-3688

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

22-MAR-08

5. Location of incident.

Country: UNITED STATES

Prov / State: OREGON

6. Date incident was first observed.

Unknown

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2596-78

Product Name: 2 in 1 Flea and Tick Powder for Cats

  • Active Ingredient(s)
    • TETRACHLORVINPHOS
      • Guarantee/concentration 3,3 %

7. b) Type of formulation.

Dust

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Animal / Usage sur un animal domestique

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

The reporter applied the product several times during February and March of 2008 to her cats in an effort to get rid of their fleas. She believes the last time she applied it was about 3/12/08.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • General
    • Symptom - Other
    • Specify - cat "faded" after the owner used the product, disappeared within 1 week of product use - no body ever found

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

1-15933424: The reporter contacted the registrant via e-mail on 3/22/08 to report that 4 of her cats had either become ill or had died after she had used a product containing the active ingredient Tetrachlorvinphos. A call was placed to the reporter in an attempt to gather additional information and render first-aid advice as appropriate. The reporter called back on 3/26/08. She stated she had begun to use the product during the 1st or 2nd week in February in an effort to get rid of her cat¿¿¿s fleas, had applied it several times, and thought the last time she applied it was about 3/22/08. The reporter revealed that 1 cat (2 year old female deaf) ¿¿¿faded¿¿¿ and then disappeared within 1 week of using the product on the cat. The reporter presumed the cat died although she never found the cat¿¿¿s body. She did not believe the cat would wander far from home as the cat was deaf. During this 3/26/08 call, the toxic profile of the product was discussed along with other possible reasons outdoor cats could develop some of the symptoms seen (e.g. ectoparasitic borne diseases).


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Minor

19. Provide supplemental information here

According to the reporter, she rescues cats and has helped 60 cats in the past 4 years. The 4 cats in question were indoor/outdoor cats who come and go as they please. She is unsure of their ages as they come to her as adult strays.

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Manx

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4.5

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Weight loss
    • Symptom - Diarrhea
  • General
    • Symptom - Lethargy
  • Renal System
    • Symptom - Renal failure
  • Gastrointestinal System
    • Symptom - Anorexia
  • Renal System
    • Symptom - Urinary incontinence
  • Blood
    • Symptom - Blood urea nitrogen increased
    • Specify - Elevated BUN and Creatinine (5 times normal levels)
  • General
    • Symptom - Dehydration
  • Nervous and Muscular Systems
    • Symptom - Abnormal gait
    • Specify - stumbling
  • General
    • Symptom - Death
    • Symptom - Weakness
    • Specify - weak
  • Nervous and Muscular Systems
    • Symptom - Disorientation
    • Specify - Dazed

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

1-15933424: The reporter contacted the registrant via e-mail on 3/22/08 to report that 4 of her cats had either become ill or had died after she had used a product containing the active ingredient Tetrachlorvinphos. A call was placed to the reporter in an attempt to gather additional information and render first-aid advice as appropriate. The reporter called back on 3/26/08. She stated she had begun to use the product during the 1st or 2nd week in February in an effort to get rid of her cat¿¿¿s fleas, had applied it several times, and thought the last time she applied it was about 3/22/08. The 2nd cat (4-5 year old Manx female) developed symptoms after the 1st cat (see 1st sub form III) had disappeared and the product was still being used. She lost weight, developed diarrhea, became lethargic, dazed and weak, began stumbling, became anorexic, and eventually became incontinent. Evaluation by a veterinarian revealed dehydration plus an elevated BUN and Creatinine (both 5 times normal). The cat was hospitalized and given fluids but died while in hospital. The only pertinent medical history prior to this illness was upper respiratory/sinus infections when she was younger. During this 3/26/08 call, the toxic profile of the product was discussed along with other possible reasons outdoor cats could develop some of the symptoms seen (e.g. ectoparasitic borne diseases).


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

According to the reporter, she rescues cats and has helped 60 cats in the past 4 years. The 4 cats in question were indoor/outdoor cats who come and go as they please. She is unsure of their ages as they come to her as adult strays.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

3

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Drooling
    • Symptom - Weight loss
  • Nervous and Muscular Systems
    • Symptom - Muscle pain
  • General
    • Symptom - Lethargy
    • Symptom - Malaise
    • Specify - Sick cat look
    • Symptom - Adipsia
    • Specify - drinking only a little
  • Nervous and Muscular Systems
    • Symptom - Muscle weakness
    • Symptom - Abnormal gait
    • Specify - Limping
    • Symptom - Other
    • Specify - Tail is "limp"
  • Respiratory System
    • Symptom - Difficulty Breathing
    • Specify - Breathing is "bad"
  • Renal System
    • Symptom - Urinary incontinence
  • Nervous and Muscular Systems
    • Symptom - Staggering
    • Specify - stumbles
    • Symptom - Difficulty walking
    • Specify - Can't put pressure on her back legs
  • General
    • Symptom - Weakness
    • Specify - weak
  • Nervous and Muscular Systems
    • Symptom - Stiffness
    • Specify - Stiff
  • Gastrointestinal System
    • Symptom - Anorexia
    • Specify - partial anorexia, eating only a little
  • Nervous and Muscular Systems
    • Symptom - Staggering
    • Symptom - Muscle pain
    • Specify - sore

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

1-15933424: The reporter contacted the registrant via e-mail on 3/22/08 to report that 4 of her cats had either become ill or had died after she had used a product containing the active ingredient Tetrachlorvinphos. A call was placed to the reporter in an attempt to gather additional information and render first-aid advice as appropriate. The reporter called back on 3/26/08. She stated she had begun to use the product during the 1st or 2nd week in February in an effort to get rid of her cat¿¿¿s fleas, had applied it several times, and thought the last time she applied it was about 3/22/08. An unknown time after product application, the 3rd cat (4 year old female) started to excessively salivate. The veterinarian recommended a course of an antibiotic, as the cat had a history of antibiotic response (Amoxicillin) gingivitis. When the cat did not respond this time, a new antibiotic (Antirobe) was tried. At the time of the 3/26/08 call, the cat had lost weight (used to be 4 lbs, now about 2.5-3 lbs), seemed to be experiencing muscle pain, was stiff, weak and stumbling, had a ¿¿¿sick cat¿¿¿ look, was lethargic, and was partially anorexic. The toxic profile of the product was discussed along with other possible reasons outdoor cats could develop some of the symptoms seen (e.g. ectoparasitic borne diseases). A recommendation was also made to conduct Cholinesterase testing as well as other diagnostics plus treatment through her veterinarian. The reporter stated she had financial constraints and ¿¿¿often had to be her own veterinarian¿¿¿. On 3/27/08, the attending veterinarian¿¿¿s office called and testing forms were faxed over. The reporter left a voice mail message on 4/1/08 in response to a follow-up call that same day. Testing samples had been obtained on the 4th cat in question (see 4th subform III), but not on the 3rd cat as the veterinarian had deemed her to be too weak. The 3rd cat was getting progressively worse and was now limping, had lost more weight, and had a limp tail with no feeling or muscle control in her tail (per the veterinarian). The reporter subsequently called on 4/3/08 with an update on the 3rd cat, who was continuing to decline. She also had a question related to treatment listed on the product label. The safety profile of the product, the inconsistency of the 3rd cat¿¿¿s progressive neurologic and musculoskeletal symptoms when compared to this profile, along with recommendations for further diagnostics and treatment through her veterinarian were discussed. The last time the reporter called back was on 4/9/08. The 3rd cat was continuing to decline ¿¿¿ limping, stiff and sore, dragging her limp tail. The cat could no longer put any pressure on her back legs and seemed to have become incontinent. The reporter thought her kidneys were failing. The case was closed on 4/14/08 since a recommendation to follow-up with the veterinarian for more intensive treatment for the 3rd cat had already been made numerous times.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Major

19. Provide supplemental information here

According to the reporter, she rescues cats and has helped 60 cats in the past 4 years. The 4 cats in question were indoor/outdoor cats who come and go as they please. She is unsure of their ages as they come to her as adult strays.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Skin
    • Symptom - Itchy skin
    • Symptom - Lesion
    • Specify - Scabs
    • Symptom - Irritated skin
    • Specify - "Tearing at her fur"

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

1-15933424: The reporter contacted the registrant via e-mail on 3/22/08 to report that 4 of her cats had either become ill or had died after she had used a product containing the active ingredient Tetrachlorvinphos. A call was placed to the reporter in an attempt to gather additional information and render first-aid advice as appropriate. The reporter called back on 3/26/08. She stated she had begun to use the product during the 1st or 2nd week in February in an effort to get rid of her cat¿¿¿s fleas, had applied it several times, and thought the last time she applied it was about 3/22/08. According to the reporter, the 4th cat (female of unknown age) was improving. She had started to scratch right after the product was applied and ended up ¿¿¿covered in scabs¿¿¿. The reporter was unsure if the cat had been reacting to the product or if she had a flea-bite allergy. She had bathed the cat in a ¿¿¿dermatitis¿¿¿ shampoo and used an alternative topical flea control product recommended by her veterinarian. During this 3/26/08 call, the toxic profile of the product was discussed along with other possible reasons outdoor cats could develop some of the symptoms seen (e.g. ectoparasitic borne diseases). A recommendation was also made to conduct Cholinesterase testing as well as other diagnostics and treatment through her veterinarian. The reporter stated she had financial constraints and ¿¿¿often had to be her own veterinarian¿¿¿. On 3/27/08, the attending veterinarian¿¿¿s office called and testing forms were faxed over. The reporter left a voice mail message on 4/1/08 in response to a follow-up call that same day. Testing samples had been obtained on the 4th cat in question, but not on the 3rd cat (3rd sub form III) as the veterinarian had deemed her to be too weak. The testing results on the 4rd cat were received 4/9/08 and revealed that the Acetylcholinesterase level was not depressed and that no pyrethroids had been detected. The presence of the alternative flea control product recommended by the attending veterinarian (Fipronil plus Methoprene) in the skin was confirmed.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here

According to the reporter, she rescues cats and has helped 60 cats in the past 4 years. The 4 cats in question were indoor/outdoor cats who come and go as they please. She is unsure of their ages as they come to her as adult strays.